The Recall Desk

Hazard

Manufacturing Defect recalls

1,441 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,441
Critical
7
Severe
114
Most recent
2026-10-21

Of the 1,441 manufacturing defect recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 114 (8%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1101–1125 of 1441

  • HighFDA (Devices)·Z-3263-2018·2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates

    Biomet UK Ltd. is recalling 44 units of the HipLOC Hip Fracture Fixation System due to an undersized bore that may prevent the lag screw from fitting.

    Product
    HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3254-2018·2018-10-03

    Intuitive Surgical Recalls da Vinci Redundant Medical Grade Power Supply Units

    Intuitive Surgical is recalling specific da Vinci Surgical System power supply units that were manufactured incorrectly and may fail during use.

    Product
    da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3211-2018·2018-09-26

    Accuray Recalls CyberKnife Calibration Film Due to Dimensional Inaccuracy

    Accuray is recalling 259 units of Ashland Box Film Ball Cube II calibration film because manufacturing defects may cause up to 0.5 mm of positional inaccuracy in CyberKnife systems.

    Product
    Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2877-2018·2018-08-29

    TriMed Ulnar Osteotomy Compression Plate Recalled for Manufacturing Defect

    TriMed Inc. is recalling 722 Ulnar Osteotomy Compression Plates because instrument holes are located on the wrong side of the plate.

    Product
    Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2876-2018·2018-08-29

    Zimmer Biomet Recalls Persona Partial Knee System Spacer Block Alignment Tower

    Zimmer Biomet is recalling 385 units of the Persona Partial Knee System Spacer Block Alignment Tower because an undersized mating feature could cause device connection issues and minor surgical delays.

    Product
    Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2794-2018·2018-08-22

    Mako Surgical Recalls Rio System Irrigation Clips Due to Tolerance Issues

    Mako Surgical Corporation is voluntarily recalling 10,606 Rio System Irrigation Clips because they are out of tolerance. The recall covers units distributed worldwide.

    Product
    Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2742-2018·2018-08-22

    Merit Medical Systems Recalls 1mL Medallion Syringes Due to Plunger Defect

    Merit Medical Systems is recalling 22,234 units of 1mL Medallion Syringes due to a manufacturing defect in the plunger tip.

    Product
    1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2736-2018·2018-08-15

    FDA Recalls iTOVi Tracker/Scanner Devices Due to Shock Complaints

    Hudson Scientific LLC is recalling iTOVi Tracker/Scanner devices because they may not meet manufacturing standards and have caused electric shocks.

    Product
    iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2432-2018·2018-07-25

    Medtronic Vectris MRI Lead Kit Recalled for Needle Defect

    Medtronic is voluntarily recalling Vectris Sure Scan MRI Lead Kits because a manufacturing defect in the curved tip introducer needle may cause difficulty advancing or withdrawing the lead.

    Product
    Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2431-2018·2018-07-25

    Medtronic Vectris Trial Screening Lead Kit Recalled for Needle Defect

    Medtronic is voluntarily recalling Vectris Trial Screening Lead Kits because a manufacturing defect in the curved tip introducer needle may cause difficulty advancing or withdrawing the lead.

    Product
    Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as additional components used for lead implant as part of a…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2256-2018·2018-06-27

    Pentax C2 CryoBalloon Focal Catheter Recalled for Connector Alignment Defect

    Pentax of America Inc is recalling 57 units of the C2 CryoBalloon Focal Catheter because a misaligned arrow may allow the catheter to detach from the controller during use.

    Product
    C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0868-2018·2018-06-20

    MBi Nutraceuticals Recalls Homeopathic Nausea Drops Due to Manufacturing Controls

    MBi Nutraceuticals is voluntarily recalling Nausea Drops and other homeopathic products due to a lack of adequate manufacturing controls.

    Product
    Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morning Sickness, and General Nausea, 1 Fl. Ounce amber glass bottle with glass dropper. MBi Nutraceuticals Lindon, UT 84042. Bar Code: 1 58301 04711 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0870-2018·2018-06-20

    MBi Nutraceuticals Recalls Stomach Calm and Other Homeopathic Products

    MBi Nutraceuticals is voluntarily recalling Stomach Calm and other homeopathic products due to inadequate manufacturing controls.

    Product
    Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz., liquid 8 ounce amber PET bottle with Black CRC Cap, MBi Nutraceuticals Lindon, UT 84042. Bar Code: 3 58301 38414 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0872-2018·2018-06-20

    MBi Recalls Homeopathic Products Due to Manufacturing Control Deficiencies

    MBi Distributing Inc. is voluntarily recalling several homeopathic products, including Argentum Elixir, due to a lack of adequate manufacturing controls.

    Product
    Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber PET bottle with white sprayer. MBi nutraceuticals Lindon UT, 84042. Bar COde: 3 58301 18114 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2111-2018·2018-06-13

    CareFusion Recalls Alaris Extension Sets Due to Incorrect Tubing

    CareFusion 303, Inc. is recalling Alaris Extension Sets with microbore tubing because manufacturing errors resulted in incorrect priming volumes.

    Product
    Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1894-2018·2018-05-30

    Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Systems for Seal Defects

    Beckman Coulter is recalling six iChem VELOCITY Automated Urine Chemistry Systems because the Strip Provider Modules were not inspected for correct seal placement and integrity during manufacture.

    Product
    iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1912-2018·2018-05-30

    Spinal Elements Recalls Omega Lumbar Interbody Fusion Devices

    Spinal Elements is recalling 19 Omega Lumbar Interbody Fusion Devices because they were assembled with components that do not match the labeled lordosis angle.

    Product
    AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1703-2018·2018-05-16

    DePuy Recalls Two Knee Implants Due to Thread Burrs

    DePuy Orthopaedics is recalling two ATTUNE Revision CRS Femoral LT knee implants because burrs may be present on the extraction hole threads.

    Product
    ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1539-2018·2018-05-09

    Beaver-Visitec Recalls Osher Thermodot Markers Due to Incorrect Tip

    Beaver-Visitec is recalling 110 Osher Thermodot Markers because they were manufactured with a needle tip instead of the proper flat tip.

    Product
    WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1528-2018·2018-05-02

    EEA Hemorrhoid Stapler Recalled for Potential Welding Defect

    FDA is recalling EEA Hemorrhoid and Prolapse Stapler Sets due to a potential welding defect that could cause bleeding or anastomotic leak.

    Product
    EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1527-2018·2018-05-02

    Recall of EEA Hemorrhoid and Prolapse Stapler Sets Due to Welding Defect

    Covidien LLC is recalling EEA Hemorrhoid and Prolapse Stapler Sets because a defective staple guide may cause bleeding or anastomotic leak during surgery.

    Product
    EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1522-2018·2018-05-02

    Zimmer Biomet Recalls Orthopedic Salvage System Locking Collars

    Zimmer Biomet is recalling Orthopedic Salvage System locking collars due to a potential dry blast irregularity on the screws.

    Product
    Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1381-2018·2018-04-25

    Zimmer Biomet Recalls Segmental System Proximal Femoral Components

    Zimmer Biomet is recalling specific proximal femoral components due to potential machining debris that may not have been adequately removed during cleaning.

    Product
    Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0630-2018·2018-04-25

    WipeEssentials Wet Wipes Recalled for Poor Quality Water

    Diamond Wipes International is recalling WipeEssentials Wet Wipes because they were manufactured with poor quality water.

    Product
    WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 66670 03988 6.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2018·2018-04-18

    ICU Medical Recalls 7-inch Intravascular Administration Sets with Incorrect Spin Collar

    ICU Medical is recalling 250 pouches of 7-inch intravascular administration sets because they were manufactured with an incorrect spin collar.

    Product
    7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for…
    Category
    Medical Device
    Distribution
    Distributed nationwide